AIMS AND BACKGROUND: To determine the efficacy and safety of the FOLFOX 2 regimen in patients with pretreated advanced colorectal cancer. METHODS: In this single-arm phase II study, 28 patients with heavily pretreated advanced colorectal cancer received the following drug combination: oxaliplatin (100 mg/m2 for 2 hrs on day 1), folinic acid (250 mg/m2 for 2 hrs on day 1) and 5-flluorouracil (1500 mg/m2 for 22 hrs continuous infusion on days 1 and 2) every 2 weeks (one cycle). The treatment was continued until unacceptable toxicity occurred or at most for 10 cycles. RESULTS: Nine patients (32%) had a partial response and 5 (18%) stable disease, with a median duration of tumor control of 24 weeks (range, 8-44). The median survival of patients with a partial response or stable disease was 32 weeks (range, 12-52), whereas the median overall survival was 32 weeks (range, 8-72). A clinical benefit was achieved in 32% (9/21) of the patients. Severe (grade 3-4) non-hematological toxicity included diarrhea (1 patient), nausea/vomiting (7%) and peripheral neuropathy (1 patient). Severe hematological toxicities were rare (4%). CONCLUSIONS: Our phase II study confirmed the therapeutic effectiveness and safety of the FOLFOX 2 regimen in pretreated advanced colorectal cancer patients.
AIMS AND BACKGROUND: To determine the efficacy and safety of the FOLFOX 2 regimen in patients with pretreated advanced colorectal cancer. METHODS: In this single-arm phase II study, 28 patients with heavily pretreated advanced colorectal cancer received the following drug combination: oxaliplatin (100 mg/m2 for 2 hrs on day 1), folinic acid (250 mg/m2 for 2 hrs on day 1) and 5-flluorouracil (1500 mg/m2 for 22 hrs continuous infusion on days 1 and 2) every 2 weeks (one cycle). The treatment was continued until unacceptable toxicity occurred or at most for 10 cycles. RESULTS: Nine patients (32%) had a partial response and 5 (18%) stable disease, with a median duration of tumor control of 24 weeks (range, 8-44). The median survival of patients with a partial response or stable disease was 32 weeks (range, 12-52), whereas the median overall survival was 32 weeks (range, 8-72). A clinical benefit was achieved in 32% (9/21) of the patients. Severe (grade 3-4) non-hematological toxicity included diarrhea (1 patient), nausea/vomiting (7%) and peripheral neuropathy (1 patient). Severe hematological toxicities were rare (4%). CONCLUSIONS: Our phase II study confirmed the therapeutic effectiveness and safety of the FOLFOX 2 regimen in pretreated advanced colorectal cancer patients.